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November 12, 2014

EbolaWatch: DARPA Offers Researchers EZ Money

  • Researchers and businesses looking to fund Ebola R&D are among those eligible for up to $700,000 in seed funds through a new U.S. Defense Advanced Research Projects Agency (DARPA) initiative.

    DARPA says EZ BAA will simplify the agency’s funding process by requiring of applicants only a two-page white paper describing their ideas. A traditional BAA or “broad agency announcement” requires forms of 40 to 60 pages and forces applicants to address a specified capability. DARPA says EZ BAA is open to any idea that can integrate biology and technology in revolutionary ways.

    Alicia Jackson, Ph.D., deputy director of DARPA’s Biological Technologies Office, said infectious disease is among key areas where EZ BAA will look to fund innovations.

    “How do we completely change the way that we deal with infectious disease today, so that we’re not reactive? You see that playing out with the crisis in West Africa, but we’re really trying to rethink that paradigm,” Dr. Jackson told reporters Thursday.

    Yet EZ BAA is looking beyond the West Africa outbreak: “We’re not interested in solving just the Ebola crisis. We want to make sure that we’re prepared for the next thing that comes down the pike that we’re not prepared for,” Dr. Jackson said, answering a GEN question.

    WHITE HOUSE OFFERS $6.8B: The Obama administration on Wednesday submitted to Congress its $6.8 billion “emergency” funding request for Ebola research, trials, and support efforts in and outside the U.S.

    On the R&D front, NIH would see $238 million toward advanced clinical trials for vaccine and drug candidates. Another $112 million would go to the Department of Defense so that DARPA can help develop stopgap treatments through antibodies from survivors, and shorten vaccine development from years to months. FDA would get $25 million for development, review, regulation, and post-market surveillance of Ebola vaccines and drugs.

    The most ($1.98 billion) would go to the U.S. Agency for International Development to bolster U.S. foreign assistance response in West Africa. Close behind with $1.83 billion would be CDC, for purposes that include:

    • Supporting 50+ Ebola Treatment Centers through state and local public health departments;
    • Improving Ebola readiness within those departments and their labs;
    • Buying personal protective equipment (PPE) for the Strategic National Stockpile;
    • Supporting increased monitoring of travelers at U.S. airports;
    • Funding infection control, contact tracing, lab surveillance and training; emergency operation centers and preparedness; education and outreach.
    • Conducting evaluations of clinical trials in affected countries.

    The Public Health and Social Services Emergency Fund (PHSSEF) would see $333 million. About half ($166 million) would fund PPE for hospitals nationwide plus the treatment centers. Another $157 million would go to the Biomedical Advanced Research and Development Authority (BARDA) toward manufacturing vaccines and synthetic therapeutics for clinical trials. Another $10 million would fund modeling and genetic sequencing of the Ebola virus.

    One research advocacy group got behind the funding request. “Americans expect our nation’s leaders to present a unified front against national threats, allocating the funding needed to protect our nation,” Research!America President and CEO Mary Woolley said.

    IMI LAUNCHES $348M “EBOLA+”: The Innovative Medicines Initiative (IMI) said Thursday it will fund Ebola research projects totaling €280 million ($348 million) through its new “Ebola+” program. IMI issued a formal Call for Proposals seeking funds for projects addressing development, manufacture, transport, and storage of vaccines; ensuring compliance with vaccine regimens; and developing rapid diagnostic tests capable of delivering reliable results in as little as 30 minutes.

    Ebola+ is intended to advance collaborations among biopharmas, and between them and universities, smaller biotechs, regulators, and other partners. The first projects are expected to begin in early 2015.

    IMI said further Calls for Proposals are planned. These will address development of: a vaccine against Ebola and related viruses; new Ebola treatments; new vaccines that do not require extreme temperatures; and new diagnostics.

    IMI is a partnership of the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

    UMBRELLA STUDY: The FDA and NIH’s National Institute of Allergy and Infectious Diseases are planning an “umbrella” clinical trial designed to assess more than one experimental Ebola treatment.

    Edward M. Cox, M.D., MPH, director of the FDA’s Office of Antimicrobial Products, told reporters his agency is working with NIAID, which has developed a protocol for the trial. It uses “innovative statistical methods that allow interim analysis, to allow a winner to be declared very early for those [treatments] that demonstrate efficacy,” he said Wednesday.

    Dr. Cox addressed reporters during the American Society of Tropical Medicine and Hygiene conference in New Orleans. A recording of the briefing has been posted on FDA’s website.

    Officials will not disclose the drugs being considered. Once a drug is found effective, it could be given to other patients in a later trial phase. “There is a tremendous urgency to figure out which among these therapies will help patients,” he added.

    rVSV-EBOV: NewLink Genetics Chairman, CEO, and CSO Charles J. Link Jr., M.D., told analysts Thursday the company is “exploring the potential for collaboration with a larger pharmaceutical company” for the experimental Ebola vaccine his company is co-developing with U.S. and Canadian partners.

    Dr. Link said also said rVSV-EBOV has been well-tolerated so far in its Phase I trial. “The first dose level in healthy volunteers at Walter Reed Medical Center has been completed and next dose level has begun,” he said on a quarterly conference call.

    A total 335 healthy volunteers will be vaccinated—20 in Germany, 100 each in Gabon and Kenya, and 115 in Switzerland. The World Health Organization (WHO) on Thursday welcomed approval by Swissmedic of the planned Swiss trial, to be led by the University Hospitals of Geneva (HUG). First vaccinations are set for the week of November 10, with first results expected in December.

    rVSV-EBOV uses weakened, genetically modified vesicular stomatitis virus (VSV) to express the glycoprotein of the Zaire Ebola virus, to provoke an immune response against real Ebola viruses. The vaccine candidate was developed by the Public Health Agency of Canada (PHAC), and licensed by PHAC to BioProtection Systems, a NewLink subsidiary.

    HEMISPHERX-USAMRIID: Hemispherx Biopharma said its marketed drug Alferon® produced in vitro data indicating that it successfully protected human cells against the Ebola virus, as did low concentrations of its drug candidate Ampligen®.

    “The overall effect is to establish a framework for clinical interventions in both preventative and therapeutic settings of Ebola virus disease (EVD) by rational combinations of the two experimental products to treat Ebola,” said Hemispherx, which is studying the drugs with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

    The company said Monday that USAMRIID plans to continue to collect data and launch in vitro synergy studies using Alferon—the only multispecies, natural alpha interferon commercially approved in the U.S.—and Ampligen, an experimental double-stranded RNA therapeutic. Alferon is indicated for refractory or recurring external genital warts caused by human papilloma virus in patients 18 years old and older.

    BREATHING EASIER: A single dose of a breathable Ebola vaccine based on an adenovirus improved the survival of immunized nonhuman primates from 67 to 100%. Protection lasted up to 150 days after immunization, according to a preclinical study led by Maria Croyle, Ph.D., of the University of Texas at Austin’s College of Pharmacy, and Gary Kobinger, Ph.D., of Canada’s National Microbiology Laboratory. Study results were published November 1 in Molecular Pharmaceutics.

    $100M MORE FROM JAPAN: Japan will spend an additional $100 million on Ebola treatment and prevention in West Africa, Chief Cabinet Secretary Yoshihide Suga said Friday, adding to $40 million committed in September by Prime Minister Shinzo Abe. The prime minister is expected to disclose details of the new spending later this month.

    $21M MORE FROM AUSTRALIA: Australia’s federal government will spend A$24 million (about $21 million) more on Ebola-fighting efforts. Funding includes an eight-month, A$20 million ($17 million) contract with Australian-based Aspen Medical to run a 100-bed field hospital in Sierra Leone. The rest will be spent on training health professionals across the Asia-Pacific region. Australia previously committed A$18 million ($15.5 million) to fight the disease.

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